Biotech Blog: A Call for a National Registry of Gene-Edited Agricultural Crops

By CSPI Biotechnology Director Greg Jaffe

April 22, 2019

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As the Biotechnology Project Director at the Center for Science in the Public Interest, I am often asked which genetically engineered (GM) crops have entered the U.S. food supply. The question can be answered with a little research because GM crops are regulated by the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA). And both agencies list on their websites all GM crops that have completed their respective regulatory process.

More recently, I have been asked the same question about gene-edited crops. Unfortunately, this time the answer is elusive. At least some gene-edited crops (such as those with small deletions) are likely to elude regulation by both USDA and FDA, so there will be no complete list of products that have concluded regulatory review and are ready for commercial production. To fix that problem, the federal government should establish a national gene-edited-crops registry so that consumers, journalists, food companies, and anyone else who is interested can easily identify the gene-edited crops and ingredients in our food. To do so will help allay consumer concerns about this emerging technology and allow the benefits of this new technology to be realized.

The Differences and Similarities between GM and Gene Editing

To create a GM crop variety, scientists typically remove a gene from some organism (a plant, animal or microorganism) and randomly introduce the gene into the target crop’s DNA using either Agrobacterium bacteria (which infect the plant’s cell and insert the new gene) or a gene gun (which shoots the new gene into the cells). The insertion process is both inefficient and imprecise, requiring the screening of many of the resulting cells to find one with the desired insertion – and nothing undesired. In most cases, the new gene produces a protein that provides the crop with a useful characteristic that it would not otherwise have. This cell is then stimulated to replicate. As of early 2019, there were commercially U.S.-grown varieties of corn, soybeans, canola, cotton, sugar beets, alfalfa, squash, papaya, apples, and potatoes that have been engineered to produce their own biological pesticides, resist plant viruses, tolerate herbicides, tolerate drought, prevent bruising, or eliminate browning.

With gene editing, scientists can make precise changes to a crop or animal’s DNA.

With gene editing, scientists can make precise changes to a crop or animal’s DNA in an easier, inexpensive, and more efficient way. While gene editing can create an altered crop variety with an added gene,similar to what can be created using Agrobacterium or the gene gun, the more exciting applications of gene editing make changes to the DNA of a crop without the addition of a gene from another organism. Scientists can, for example, delete small or large segments of DNA to turn off or eliminate one or more genes. Or they can replace one or more DNA base pairs to correct a mutation in a defective gene. They can even add additional copies of an existing gene to increase the production of a desirable molecule.

To make the desired changes, scientists program biological molecules—which go by exotic names like Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9—to recognize a specific location in the crop’s DNA, cut the DNA at that location, and implement the desired change. At times, this process can result in “off-targets,” where the DNA is altered at locations in the organism other than the intended site. Before a product is commercialized, any off-targets need to be assessed to ensure they do not have a detrimental effect on the plant—or humans and animals eating products made from the plant. Some gene-edited crops created by scientists in the laboratory, but not yet on the market, include: non-browning mushrooms, waxy corn, slow-growing cabbage, and mildew-resistant grapes.

Lack of Federal Oversight for Some Gene-Edited Agricultural Products

The GM crops currently in the U.S. food supply have all been reviewed by both the USDA and the FDA. The USDA requires that GM crops that could pose a “plant pest” risk (i.e., become an organism which harms plants or plant products) be grown in a confined field until the USDA determines that the crop doesn’t pose such a risk, and can then be “deregulated” and marketed to farmers without restrictions. Every GM crop currently being grown has ultimately been deregulated by USDA. (You can see the petitions for nonregulated status and the USDA’s final determinations at here). Future GM crops are not likely to receive that same level of oversight (or any oversight at all) because USDA may no longer consider them potential plant pests, but that is a topic for another article.

While the FDA’s consultation process is voluntary, all GM crops currently grown by U.S. farmers have gone through it. (You can see the developers’ submissions and the FDA’s responses here.) CSPI is on record advocating that all GM crops should be required to go through FDA’s consultation process and FDA should publicly state its opinion on their safety at the conclusion of the review.

If consumers believe that key information about a food is being hidden from them, they may question the food’s safety or quality.

While the federal oversight scheme for gene-edited crops is still evolving, all signs point to a future with little or no oversight for many of the gene-edited deletions/replacements mentioned above. Since 2015, at least 11 developers of gene-edited crops have used the USDA’s “Am I regulated?” process to ask whether they are subject to the “plant pest” regulations for GM crops. Without exception, they have been told that their products fall outside the scope of the regulations and therefore don’t need the USDA’s approval. In a March 2018 press release, Agriculture Secretary Sonny Perdue said that unless a gene-edited crop is a potential “plant pest,” the USDA will not regulate it. Given that statement, future developers likely will not even submit “Am I regulated?” inquiries, leaving the USDA—and the public—with no information about which gene-edited crops are being developed or when they might enter the food supply. The FDA hasn’t said whether gene-edited crops should submit to voluntary consultation, but even if the agency asked them to, this would leave much in the hands of the developers. There is no way to know if any gene-edited products have submitted consultation applications before the consultation is completed (at which point successful applications are posted).

Transparency as a Benefit of Regulation

While the primary purpose of the regulatory system is to ensure that GM crops are safe, a corollary benefit is that it can provide transparency about emerging products and their current stage of development. Since many gene-edited products could escape oversight, they could become invisible to consumers. That’s because developers (seed companies) usually communicate with their immediate customers (typically farmers), and not anyone else along the food chain. The same thing happened with many GM crops. Monsanto, for example, touted the benefits of its glyphosate-tolerant soybeans and corn crops to farmers, but neither Monsanto nor food companies made consumers aware that they were eating foods made from those products. It is this lack of transparency that in part explains why GM crops have encountered consumer skepticism.

Are Gene-Edited Crops in the Food Supply?

Most people can’t tell whether foods and ingredients came from gene-edited crops. One would need intimate familiarity with the regulatory process and the current companies conducting gene editing to know that. Currently, there are two gene-edited crops that have entered the food supply: Calyxt has used TALENS to produce high oleic soybeans (which have a healthier oil profile than normal soybeans) that are crushed into oil for humans and soybean meal for animals. In a recent press release, the company announced that 34,000 acres of its soybeans would be grown in 2019, double what was grown in 2018. And Cibus has been selling farmers herbicide-tolerant gene-edited canola that is also processed into oil. Interestingly, Calyxt completed both the USDA’s “Am I regulated?” process and the FDA consultation process whereas there is no record of Cibus completing either one.

It is the lack of transparency that in part explains why GM crops have encountered consumer skepticism.

But here’s what worries me: there may be more gene-edited products that we don’t know about. In the future, even someone with expertise and access to information might not be able to keep track of all the developers who are using gene editing. And that means the food industry and consumers might have no idea which foods could contain ingredients that came from gene-edited crops.

The Need for a National Registry

If we learned anything from the controversy over GM crops, it is that if consumers believe that key information about a food is being hidden from them, they may question the food’s safety or quality, and may leave it on the grocery store shelf. It is only a matter of time before consumers start asking retailers like Wegmans or Walmart or food manufacturers like Kellogg or General Mills whether they sell foods that contain gene-edited ingredients. If those companies don’t even know which gene-edited crops are being grown, how can they approach suppliers to find out if they use ingredients from those gene-edited crops? More importantly, for the sake of transparency, food companies and retailers need to make this information available before consumers ask for it, so that people don’t think the food industry is hiding anything from them.

Transparency can also help consumers realize that gene editing isn’t necessarily bad—that it can produce more-nutritious foods or crops that have less impact on the environment. However, that can’t happen if no one—not consumers, and not even manufacturers and retailers—knows which gene-edited crops are being grown and the benefits achieved by the gene-editing.

Finally, information about which gene-edited products are in the marketplace is critical for international trade. Without that information, a country with concerns about gene editing may put up trade barriers if it believes gene-edited products are being grown in the U.S. that have not been through the importing country’s regulatory procedures. No one wants a repeat of what happened when cargo ships were not allowed to offload U.S.-grown GM grains in China in 2013 because a GM corn variety approved in the U.S. but unapproved in China was found onboard. Some countries may go one step further and not import a crop if any gene-edited variety of a crop exists in the exporting country. The USDA and other agencies currently certify some crops as non-GM so they can be exported to certain countries. A government-managed national registry will facilitate trade of both gene-edited and non-gene-edited crops and make it easier for companies to give consumers what they want.

Food companies and retailers need to make this information available before consumers ask for it.

To provide information about gene-edited crops in the U.S. food supply, a national registry hosted by the USDA or the FDA should be established. Gene-edited-crop developers would be required to fill out a short form—a “gene editing data sheet”—with information about the crop, the type of edits performed, the changed characteristics due to the edits, and a summary of data about the benefits of the trait and any testing for safety concerns. These sheets could be uploaded into a public database, and a summary of all the data sheets could be generated, making it easy for anyone to quickly determine which crops and/or traits are in the food supply. That information would allow all relevant stakeholders to engage in meaningful conversations around utilization, acceptance, benefits, and impacts of this technology and its products. A recent World Health Organization panel recommended the establishment of a similar registry to catalogue global human gene-editing research.

No matter how people feel about gene-edited crops and whether they believe substantive oversight for safety is necessary, everyone should embrace a national registry, which would at least provide a minimum amount of information to the public and interested stakeholders.

Gregory Jaffe

Gregory Jaffe is the Director of the Project on Biotechnology for CSPI. Jaffe came to CSPI after serving as a Trial Attorney for the U.S. Department of Justice's Environmental and Natural Resources Division and as Senior Counsel with the U.S. EPA, Air Enforcement Division. He is a recognized international expert on agricultural biotechnology and biosafety and works on biosafety regulatory issues in the U.S. and throughout the world. He was a member of the Secretary of Agriculture's Advisory Committee on Agricultural Biotechnology and 21st Century Agriculture from 2003-2008 and was reappointed to a new term in 2011. He was also a member of FDA’s Veterinary Medicine Advisory Committee from 2004-2008. In addition, he provides biosafety expertise to the International Food Policy Research Institute and Cornell University’s Alliance for Science. Jaffe earned his BA with High Honors from Wesleyan University in Biology and Government and then received a law degree from Harvard Law School.